Registration: Why It’s Important

Last Wednesday, I posted the proposed bill, H.R.4262 Cosmetics Safety Enhancement Act of 2012. I’m not touching on the finer points of this legislation today, as we are still going through it with a fine tooth comb. However, Section 604 got me thinking about something we covered last year and I wanted to take it a step further.

When I formulated products, I participated in the VCRP. It was remarkably easy and the information asked was very minimal. I registered my company, my individual products and the ingredients for those products. When listing ingredients with the VCRP, it’s no different than listing them on a website or a product label. They are listed the same way in the VCRP; in descending order of predominance.

Why is it important to register your company, products and ingredients? As I asked Don Havery in the VCRP post above, I will share this main questions again:

Why should a manufacturer register with the VCRP?

The VCRP helps FDA in its mission to protect consumers. It also helps cosmetic manufacturers and distributors make informed decisions about ingredient use in their products. For example, if it is determined that a cosmetic ingredient presently being used is harmful and should be removed from product use, FDA can notify the manufacturers and distributors of affected products. Since the VCRP is the only source of information about what products are on the market, firms that do not participate in the program won’t receive that information directly. Information from the VCRP database also assists the Cosmetic Ingredient Review (CIR) Expert Panel in determining its priorities for ingredient safety review. The CIR is an industry-funded panel of scientific experts that regularly assesses the safety of cosmetic ingredients. Since cosmetic manufacturers are responsible for assuring that their products and the ingredients in them are safe, participating in the VCRP is one way of supporting the safety review process since VCRP data is used to by the CIR safety review program (See http://www.cir-safety.org).

Now I’d like to share a scenario with you:

Manufacture A is formulating product X, using ingredient Z, and has registered their company, products and ingredients with the FDA.

Manufacturer B is formulating product Y, using ingredient Z, and has not registered their company, products and ingredients with the FDA.

The FDA recalls ingredient Z, and sends out an email alert telling all the companies that have registered their company, products and ingredients with the FDA, to stop using ingredient Z.

Manufacture A removes ingredient Z from their raw material inventory, and recalls all products that contain ingredient Z, that may be in the marketplace.

Manufacturer B is continuing to formulate using ingredient Z because they did not receive an email. Why? Because the FDA was unaware they were using ingredient Z.

Do you see where I am going with this? How is manufacturer B supposed to know that ingredient Z can no longer be used in formulating a product? Sure, manufacturer B can scour the FDA website, the Cosmetic Ingredient Review website or other sites that would post this information, but what if they miss it? Quite frankly, I wouldn’t want to take that chance of not being made aware of an ingredient recall.